Weekly Roundup – 6-28-13

Where does the time go?  One minute dandelions are yellow and before you know it, they are fuzzy and blowing away in the wind….

It has been quite a week outside of our little world.  The Supremes sure were busy and did some stopping in the name of love.  In the meantime, here is a little of what happened that, while less momentous, is noteworthy.

  • FDA Approves 1st Recombinant Coagulation Factor IX for Prophylactic Use – We always love firsts and one happened this week when FDA announced approval of Baxter’s Rixubix for use in people with hemophilia B over 16 years of age for the controla nd prevention of bleeding episodes, perioperative management and routine use to prevent or reduce the frequency of bleeding as a prophylaxis.
  • Agency Announces 1st Decisions on New Tobacco Products Thru Substantial Equivalence Pathway – Yes, another first!  The Family Smoking Prevention and Tobacco Control Act of 2009 authorized FDA to review tobacco products to be marketed to determine if they are substantially equivalent to a valid predicate product already on the market.  In doing so, FDA determined that out of six reviews, two new products could be marketed and denied four others.  According to the agency’s release, any product that raises different questions of public health will be found to be not substantially equivalent and FDA said that a variety of factors went into the decision against the four that did not receive marketing authorization.  These decisions will provide the first insight into the agency’s approach to approval and non-approval.
  • FDA Takes Action Against Websites Selling Prescription Products The agency announced this week that it had taken action against more than 9,600 websites that were illegally selling unapproved prescription medications to consumers as part of a global effort and in partnership with other regulatory bodies around the globe.  FDA said that the websites displayed fake licenses and certifications to appear legitimate.  The actions taken by FDA and the regulatory agencies involved the issuance of warnings and the seizure of offending websites as well as illegal medicines.

That’s it for me this week folks and I am sorry I was late to press today.  Busy week!  Hope you all have a wonderful weekend as we slip into July together….

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